Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms (ACT-PM)

Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms: An Open-label Feasibility Study of ACT-PM

In the weeks prior to menstruation, many individuals experience mood and physical symptoms that negatively impact their quality of life and functioning. Approximately 5% of women and menstruating individuals have such severe symptoms that they meet criteria for Premenstrual Dysphoric Disorder (PMDD). Further, of those with underlying mood disorders (i.e., depression, bipolar disorder) about 60% have cyclical worsening of symptoms classified as premenstrual exacerbation (PME). Both PMDD and PME are associated with significant impairment, yet limited effective options exist to treat these conditions. In this project, the investigators will adapt and evaluate an Acceptance and Commitment Therapy (ACT) group for PMDD and PME, entitled ACT-Premenstrual (ACT-PM), delivered virtually to maximize accessibility. The investigators will examine whether ACT-PM is feasible to deliver and whether it is acceptable to group participants and those facilitating the group. The study will lay the groundwork for future research to determine if the group is effective. If effective, the intervention could be scaled up to improve quality of life and outcomes for individuals suffering from PMDD and PME.

Study Overview

• Status: Active, not recruiting
• Conditions: Premenstrual Dysphoric Disorder; Premenstrual Exacerbation of Mood Disorder
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy (ACT) Group

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital
    • Toronto, Ontario, Canada, L5M6N8
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) diagnosed by the psychiatrist who conducted the initial assessment with either Premenstrual Dysphoric Disorder (PMDD), or a bipolar or depressive disorder where there is Premenstrual Exacerbation (PME), after 2-3 months of mood tracking using a validated evidenced based scale for premenstrual mood symptoms (McMaster Premenstrual And Mood Symptom Scale (MAC-PMSS) or similar;
• (2) have internet access and a video-enabled device;
• (3) residing in Ontario for the duration of the study, necessary because MDs and therapists who could deliver the intervention are all licensed provincially;
• (4) regular menstrual cycles (~21-35 days); and
• (5) have a regularly treating physician (e.g. psychiatrist or primary care provider).

Exclusion Criteria:

• (1) active alcohol or substance use disorder in the previous 12 months;
• (2) active suicidal ideation, mania, psychosis, or violence;
• (3) current pregnancy or planning a pregnancy during the duration of the study
• (4) inability to complete group and/or study measures in English, necessary as the pilot group is only available in English at this time.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: single arm (open label); all participants will be in pilot psychotherapy group	Behavioral: Acceptance and Commitment Therapy (ACT) Group; Psychotherapy group (delivered virtually)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment and enrollment: number of participants referred	Tracking to see how many referrals are made to the study	Screening and baseline
Feasibility of recruitment and enrollment: number of participants eligible	Tracking number of participants that were eligible out of the number that was referred	Screening and baseline
Feasibility of recruitment and enrollment to study: number of participants enrolled	Tracking number of participants that enrolled into the study	Screening and baseline
Feasibility of recruitment and enrollment to study: reasons for non-participation	Tracking number of participants who did not enroll into the study and any reasons given by these participants	Screening and baseline
Adoption outcome: group attendance	Tracking group attendance per session	During intervention, post-intervention (after 8 weeks of intervention)
Adoption outcome: group completion	Tracking how many participants completed the group	During intervention, post-intervention (after 8 weeks of intervention)
Adoption outcome: reasons for non-completion	Tracking the reasons why participants did not complete the group	During intervention, post-intervention (after 8 weeks of intervention)
Acceptability outcome	Determining the acceptability of the program among participants and facilitators via questionnaires about their experience in the program.	Post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Adherence with intervention protocol: therapist adherence	(1) assessing therapist adherence to ACT-PM intervention via self-report from therapists and (2) independent rater review of 10% of audio tapes of sessions using ACT-FM (The ACT Fidelity Measure)	During and post-intervention (after 8 weeks of intervention)
Adherence with intervention protocol: completion of participant questionnaires	Tracking number of participants who completed data collection measures (i.e.. acceptability questionnaire, and clinical scales - described below)	Baseline, during intervention, post-intervention (after 8 weeks of intervention), and at 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory clinical symptoms outcome: McMaster Premenstrual And Mood Symptom Scale (MAC PMSS)	Individuals can track their mood and premenstrual symptoms on a daily basis using the validated and self-reported McMaster Premenstrual And Mood Symptom Scale (MAC PMSS). The MAC PMSS consists of two charts 1) mood symptom chart, 2) premenstrual symptom chart with severity scores ranging from 1 (not at all) to 6 (extreme). Higher scores indicate a worse outcome.	Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Exploratory clinical symptoms outcome: Premenstrual Symptoms Screening Tool (PSST)	Premenstrual Symptoms Screening Tool (PSST) is a validated questionnaire which consists of 19 questions regarding how symptoms interfere with relationships and daily activities -14 questions are related to premenstrual symptoms, and 5 questions that measure the severity of interference of the symptoms on a woman's ability to function. The scale of each item ranges 0-3: not at all (0); mild (1); moderate (2); severe (3). Higher scores indicate a worse outcome.	Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Exploratory clinical symptoms outcome: The Patient Health Questionnaire-9 (PHQ-9)	9-item assessment for depression, with scores indicating how often symptoms are bothersome, ranging from 0 (not at all) to 3 (nearly every day). Higher scores indicate a worse outcome.	Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Exploratory clinical symptoms outcome: The Generalized Anxiety Disorder-7 (GAD-7)	The GAD-7 a 7-item well-validated self-report scale which can aid in diagnosis and severity assessment for anxiety disorders (including GAD, social anxiety disorder, post-traumatic stress disorder, panic disorder). It is sensitive to change across treatment. Score ranges are from 0-21, with scores of 0-4 representing minimal, 5-9 mild, 10-14 moderate, and 15-21 severe anxiety symptoms.	Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Exploratory clinical symptoms outcome: The Acceptance and Action Questionnaire (AAQ-II)	The AAQ-II is a 7-item self-report scale that assesses constructs relating to acceptance, experiential avoidance, and psychological inflexibility, which are targets of Acceptance and Commitment Therapy (ACT). It has demonstrated satisfactory reliability and validity, has been validated in psychiatric populations, and scores are predictive of mental health and functional outcomes. Higher scores indicate less (worse) flexibility.	Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Exploratory clinical symptoms outcome: The Mindfulness Attention Awareness Scale (MAAS)	The MAAS is a 15-item self-report scale-used previously in both ACT and PMS research-to assess components of mindfulness such as present-moment awareness and observing capacity, which are considered transdiagnostic processes underlying various forms of psychopathology. Higher scores indicate less mindfulness (worse).	Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Exploratory clinical symptoms outcome: The Valuing Questionnaire (VQ)	The VQ is a 10-item self-report measure that was developed to assess changes in a target of ACT-valued living. Its' 2 subscales are correlated strongly with measures of emotional/affective symptoms and life satisfaction. In scoring, higher scores on the Progress scale are associated with health, as are lower scores on the Obstruction scale.	Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up
Exploratory clinical symptoms outcome: The Emotion Regulation Questionnaire (ERQ).	The ERQ is a 10-item self-report measure designed to assess individuals' tendency to regulate their emotions through Cognitive Reappraisal and Expressive Suppression. Emotion regulation is a target in ACT therapy. To score the ERQ, the average of the scores in each subscale - (i) cognitive reappraisal and (ii) expressive suppression are taken. The higher the score, the greater the use of that particular emotion regulation strategy - cognitive reappraisal is considered adaptive (thus higher scores are better) and expressive suppression maladaptive (lower scores are better).	Baseline, post-intervention (after 8 weeks of intervention), and at 3-month follow-up

Collaborators and Investigators

• Sponsor: Women's College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Menstruation Disturbances; Premenstrual Syndrome; Pathological Conditions, Signs and Symptoms; Premenstrual Dysphoric Disorder; Population Characteristics; Demography; Population Groups
• Other Study ID Numbers: WCH-24-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No